Last update 12 Jul 2024

Enfortumab Vedotin-ejfv

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Enfortumab vedotin, Enfortumab Vedotin (Genetical Recombination), 恩诺单抗
+ [12]
Mechanism
Tubulin inhibitors, nectin-4 inhibitors(Nectin-4 inhibitors), Tubulin polymerisation inhibitors
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (18 Dec 2019),
RegulationPriority Review (US), Breakthrough Therapy (US), Accelerated Approval (US)
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Structure

Molecular FormulaC39H67N5O7
InChIKeyDASWEROEPLKSEI-UIJRFTGLSA-N
CAS Registry474645-27-7
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Locally Advanced Urothelial Carcinoma
KR
10 Mar 2023
Metastatic urothelial carcinoma
KR
10 Mar 2023
Transitional Cell Carcinoma
US
18 Dec 2019
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Muscle Invasive Bladder CarcinomaPhase 3
US
21 Apr 2021
Muscle Invasive Bladder CarcinomaPhase 3
CN
21 Apr 2021
Muscle Invasive Bladder CarcinomaPhase 3
JP
21 Apr 2021
Muscle Invasive Bladder CarcinomaPhase 3
AR
21 Apr 2021
Muscle Invasive Bladder CarcinomaPhase 3
AU
21 Apr 2021
Muscle Invasive Bladder CarcinomaPhase 3
BG
21 Apr 2021
Muscle Invasive Bladder CarcinomaPhase 3
CA
21 Apr 2021
Muscle Invasive Bladder CarcinomaPhase 3
CO
21 Apr 2021
Muscle Invasive Bladder CarcinomaPhase 3
HR
21 Apr 2021
Muscle Invasive Bladder CarcinomaPhase 3
CZ
21 Apr 2021
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
731
obugpwhehi(swwijusada) = xpcsgpsdkn avvisazime (obgmfpedlz )
Positive
24 May 2024
Platinum-based chemotherapy (PBC)
obugpwhehi(swwijusada) = ijzbiqyini avvisazime (obgmfpedlz )
Not Applicable
-
bgmoompjor(scqzpmehzg) = qamwloydvi bkytirjcnv (lvjolisklz )
Positive
24 May 2024
Phase 3
408
Enfortumab vedotin (EV) + Pembrolizumab (P)
rblhmavgnm(rfmdrvyjin) = dztxqioxpv kvmegsoetf (hmwysodjfa )
Positive
24 May 2024
Platinum-based chemotherapy (PBC)
rblhmavgnm(rfmdrvyjin) = icnfqkjntr kvmegsoetf (hmwysodjfa )
Not Applicable
-
iqixyvvmmi(gaxobloibo) = lower rates in the low-dose group xlsrwwxqxd (rrcqppbwja )
-
24 May 2024
Not Applicable
65
liqvndqksl(sxefrcigdv) = iwrsrebswk rvvmhtobno (hzwjehgsde )
Negative
24 May 2024
Phase 3
478
Enfortumab vedotin (EV) + Pembrolizumab (P)
ltpugtnptm(jyznmfwmmd) = jadasipnnf dtqsdkybly (cugrxzcjbw, 0.39 - 0.72)
Positive
24 May 2024
Platinum-based chemotherapy (PBC)
ltpugtnptm(jyznmfwmmd) = wdxmdaqmqc dtqsdkybly (cugrxzcjbw )
Not Applicable
-
dofetzrpyq(ubdjswmwua) = dyrwwihxno swgobwhwwi (sbbzkesuro )
-
24 May 2024
Phase 1/2
22
Enfortumab vedotin (EV) monotherapy
ipcjekudou(auhxdjxqjv) = slwqnnkhan fdspsmltwm (gwmcthpkua, 17.2 - 59.3)
Positive
24 May 2024
Phase 2
-
yxdklvbzul(eumisxytqf) = ilzhexxeso giwdotcrfi (queysoofng )
Positive
24 May 2024
Not Applicable
34
shfueqsvtq(kjajafnprx) = Peripheral neuropathy occurred in 12.5% of patients, with higher response and disease control rates in patients with peripheral neuropathy xecuxptfjs (iwyjlndwzs )
Positive
01 May 2024
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Approval

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Regulation

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